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Isolated Hepatic (Liver) Perfusion With Melphalan Followed By Temozolomide in Treating Patients With Unresectable Liver Metastases From Ocular (Eye) Melanoma
This study has been completed.

First Received on August 6, 2003.   Last Updated on February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066521
  Purpose

RATIONALE: Drugs used in chemotherapy such as melphalan and temozolomide use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of isolated hepatic (liver) perfusion with melphalan followed by temozolomide in treating patients who have unresectable liver metastases that has resulted from ocular (eye) melanoma.


Condition Intervention Phase
Intraocular Melanoma
Metastatic Cancer
 Drug: isolated perfusion
Drug: melphalan
Drug: temozolomide
Procedure: adjuvant therapy
 Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma
MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Temozolomide Melphalan Sarcolysin Melphalan hydrochloride
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of responders with response duration > 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2003
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate and duration of response in patients with unresectable hepatic metastases secondary to ocular melanoma treated with isolated hepatic perfusion with melphalan followed by temozolomide.
  • Determine the pattern of recurrence in patients treated with this regimen.
  • Determine the disease-free and overall survival of patients treated with this regimen.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients who are otherwise eligible undergo exploration through a limited incision. Patients with peritoneal seeding or unresectable extrahepatic metastatic disease are removed from study. All other patients undergo isolated hepatic perfusion (IHP) and receive melphalan intra-arterially over 1 hour.

Within 8-12 weeks after IHP, patients are re-evaluated by MRI. Patients with stable or responding disease receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 8-12 weeks after IHP, every 3 months during temozolomide, and at all follow-up visits.

Patients are followed every 3 months for 2 years and then every 4 months thereafter.

PROJECTED ACCRUAL: A total of 9-40 patients will be accrued for this study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed ocular melanoma

    • Metastatic disease confined to the liver
    • Limited sites of extrahepatic disease allowed, provided the dominant life-limiting disease is in the liver and the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy)
  • Measurable disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count greater than 75,000/mm^3
  • Hematocrit greater than 27%
  • Absolute neutrophil count at least 1,500/mm^3

Hepatic

  • Bilirubin less than 2.0 mg/dL
  • PT no greater than 2 seconds above the upper limit of normal (ULN)
  • AST and ALT no greater than 10 times ULN
  • No biopsy proven cirrhosis
  • No evidence of significant portal hypertension by history, endoscopy, or radiologic study

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • No history of congestive heart failure with LVEF less than 40%
  • No history of veno-occlusive disease

Pulmonary

  • No chronic obstructive pulmonary disease
  • No other chronic pulmonary disease with pulmonary function tests less than 50% of predicted

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Weight greater than 30 kg
  • No active systemic infection
  • No prior hypersensitivity reaction to melphalan, dacarbazine, or temozolomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior biologic therapy for the malignancy

Chemotherapy

  • More than 28 days since prior chemotherapy for the malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 28 days since prior radiotherapy for the malignancy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • No concurrent chronic anticoagulation therapy
  • No concurrent immunosuppressive drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066521

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Steven K. Libutti, MD NCI - Surgery Branch
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00066521     History of Changes
Obsolete Identifiers: NCT00062933
Other Study ID Numbers: CDR0000316262, NCI-03-C-0221
Study First Received: August 6, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
liver metastases
recurrent intraocular melanoma
metastatic intraocular melanoma
extraocular extension melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Eye Neoplasms
Neoplasms by Site
 Eye Diseases
Uveal Diseases
Melphalan
Temozolomide
Dacarbazine
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012



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